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FDA 510(k)

GOLD FOIL ERG ELECTRODES

K-Number: K820254 · 1982-04-09

ApplicantCadwell Laboratories, Inc.
Decision Date1982-04-09
Product CodeHLZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

GOLD FOIL ERG ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Laboratories, Inc.. It received FDA 510(k) clearance on 1982-04-09 under 510(k) number K820254. The device is classified under product code HLZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOLD FOIL ERG ELECTRODES?

GOLD FOIL ERG ELECTRODES is a medical device that received FDA 510(k) clearance on 1982-04-09. The listed applicant is Cadwell Laboratories, Inc.. The 510(k) number is K820254.

When did GOLD FOIL ERG ELECTRODES receive FDA 510(k) clearance?

GOLD FOIL ERG ELECTRODES received FDA 510(k) clearance on 1982-04-09, under 510(k) number K820254.

Who is the listed applicant for GOLD FOIL ERG ELECTRODES?

The FDA 510(k) record lists Cadwell Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GOLD FOIL ERG ELECTRODES?

The FDA product code for GOLD FOIL ERG ELECTRODES is HLZ.

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Other records listing Cadwell Laboratories, Inc. as applicant

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Related Devices (Code: HLZ)

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K253586RM Electrode (RMH 25-01)Retmap, Inc.K232273RM Electrode (RMH 23-01)Retmap, Inc.K961805TOMEY DTL ELECTRODETomey Corporation USAK926540SOPHER AND BIERER OVUM FORCEPSThomasville Medical Assoc.K913239GOLDLENS(TM)Doran Instruments, Inc.K844409DTL ELECTRODESauquoit Industries, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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